Details

Autor(en) / Beteiligte

• Reddy, Vivek Y
• Knops, Reinoud E
• Sperzel, Johannes
• Miller, Marc A
• Petru, Jan
• Simon, Jaroslav
• Sediva, Lucie
• de Groot, Joris R
• Tjong, Fleur V.Y
• Jacobson, Peter
• Ostrosff, Alan
• Dukkipati, Srinivas R
• Koruth, Jacob S
• Wilde, Arthur A.M
• Kautzner, Josef
• Neuzil, Petr

Titel

Permanent Leadless Cardiac Pacing: Results of the LEADLESS Trial

Ist Teil von

• Circulation (New York, N.Y.), 2014-04, Vol.129 (14), p.1466-1471

Ort / Verlag

Hagerstown, MD: by the American College of Cardiology Foundation and the American Heart Association, Inc

Erscheinungsjahr

2014

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• BACKGROUND—Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker. METHODS AND RESULTS—The primary safety end point was freedom from complications at 90 days. Secondary performance end points included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance). The mean age of the patient cohort (n=33) was 77±8 years, and 67% of the patients were male (n=22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n=22, 67%). The implant success rate was 97% (n=32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. CONCLUSIONS—In a prospective nonrandomized study, a completely self-contained, single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing. CLINICAL TRIAL REGISTRATION—URLhttp://clinicaltrials.gov. Unique identifierNCT01700244.